One of the major bottlenecks in the production of biopharmaceuticals is the efficient expression of therapeutic proteins in microbial or mammalian cells.
Fujifilm Diosynth Biotechnologies is one of the world’s leading providers of contract process development and manufacturing services for the biopharmaceutical industry.
Formed in April 2011, the company has more than 900 employees operating from two sites in Billingham, UK, and Research Triangle Park, North Carolina, US.
Together we have more than 15 years of experience working with over 230 complex proteins, and both sites have been successfully FDA inspected for the manufacture of commercial products, demonstrating our strong track record in navigating the critical path through validation and regulatory approval.
Over the last 12 months, we have announced additional mammalian cell culture capacity at both our RTP site (commissioned early 2012) and a new cGMP mammalian cell culture facility at our Billingham, UK site (commissioned Q3 2013).
Fujifilm Diosynth Biotechnologies
A ‘one-stop-shop’ is available for antibody drug conjugate (ADC) development through our alliance with Piramal Healthcare. The combined ADC development between Fujifilm and Piramal ensure rapid conjugation demonstration and route to market.
Biologics process development
As a full-service contract manufacturer, we offer an extensive breadth of process development capabilities to meet our customers’ needs at every stage of the product lifecycle.
Our experience ensures process development is applied appropriately, dependent upon the development needs of customer products at different clinical stages.
- A wide range of constructs and expression options including development of a customer’s existing system or creating one de novo from our family of microbial therapeutic protein production systems, including our pAVEway system
- Microbial capability in the development laboratories include multiple 5l, 15l and 140l fermenters
- Mammalian cell line development capability
- Mammalian capability in the development laboratories include multiple 2l, 5l, 10l, 15l, 20l and 110l bioreactors, wave 20/50, and 2 x 200l Xcellerex systems
- 100l scale pre-cGMP pilot plant for process demonstration and supply of pre-clinical material
Biologics cGMP manufacturing
At our sites in Billingham, UK, and Research Triangle Park, NC, US, we offer a broad range of mammalian and microbial cGMP manufacturing capabilities. We employ protocol-driven technology transfer processes to bring in projects from customers and seamlessly integrate them into these facilities. Our facilities have received successful regulatory inspections from all key regulatory agencies.
- Various scales for rapid cGMP manufacture of material for Phase I-III clinical supply, process validation and commercial supply from 100l to 5,000l
- Flexible plant configurations including disposables technology and refold volumes of up to 10,000l
- 2 x 110l and 1 x 2,000l train (20l,145l, 650l) for cGMP manufacture of material for Phase I-III clinical supply, process validation and commercial supply
- 1 x 1000l single-use bioreactor at RTP site; 1 x 200l and 1 x 1,000l single-use bioreactor at Billingham site; 1 x 2000l single-use bioreactor planned for 2014 at Billingham site.
Biologics manufacturing support services
The following additional services are offered to reduce complexity and risk of multiple suppliers:
- cGMP cell banking facilities for production of master and working cell banks
- Buffer screening studies to support downstream process development
- Development of stable product formulations
- Full range of in-house analytical methods
- Full range of stability testing capabilities for drug substance and drug product
Quality and regulatory support for biopharmaceutical development and manufacturing
Our aims include:
- To ensure our customers’ products meet international regulatory requirements, we provide all the necessary quality and regulatory support through an independent quality unit
- Regulatory support for IND / CTA submission, DMF and CMC as required
- QC analysis and release of raw materials, environmental and water in-process / final, sample retention
- Ownership and use of qualified or validated methods
- Quality agreement followed by routine interactions with customer throughout the programme
Antibody drug conjugation
We can also offer a ‘one-stop-shop’ for antibody drug conjugates through our alliance with Piramal Healthcare. Through our rapid delivery of ADC drug substance, simplified supply chain and aligned mAb and ADC programmes the benefits include:
- Early transfer of material from Fujifilm to Piramal: rapid demonstration of conjugation
- Transfer of analytical methods from Fujifilm to Piramal
- Integrated programme management teams
Fujifilm Diosynth Biotechnologies (FDB) embarked on an expansion of its flexible biomanufacturing facility at its College Station location in Texas, US, in February 2020.
Samsung BioLogics opened its third biologics manufacturing plant in Songdo, South Korea, in October 2018. The plant made Samsung Group one of the world’s largest biologics contract manufacturing operators (CMO) in the world.
In February 2018, Ferring Pharmaceuticals announced plans to build a new biotechnology centre at its headquarters in Saint-Prex, Switzerland.
Chinese company Clover Biopharmaceuticals plans to build a new biomanufacturing facility in the Changxing Economic and Technological Development Zone (CETDZ) of Zhejiang, China.
Pfizer broke the ground for the development of a Global Biotechnology Centre in the Hangzhou Economic Development Area (HEDA) in China on 27 June 2016.
FUJIFILM Diosynth Biotechnologies has announced the continued expansion of its cell culture manufacturing capabilities with the addition of two 2,000l single-use bioreactors. One of each of these is being installed at the company's sites in Research Triangle Park (RTP), NC, US and Billingham, UK.
Fujifilm Diosynth Biotechnologies has announced continued expansion of its process development capabilities with the investment of over $5.6m in new laboratories and equipment at both its Billingham, UK, and Research Triangle Park (RTP), NC, US sites.
Fujifilm Diosynth Biotechnologies has formally opened its new UK mammalian cell culture cGMP manufacturing facility at a ceremony performed by HRH the Duke of Gloucester.
Fujifilm Diosynth Biotechnologies has announced that it has received a renewal of its manufacturer's licence from the UK's Medicines and Healthcare products Regulatory Agency (MHRA).
Fujifilm Diosynth Biotechnologies has announced that it has commissioned on time its new mammalian cGMP Cell Banking Facility (CBF) at its Billingham, UK site.
Fujifilm Diosynth Biotechnologies has added another licensed product to its list of commercial biopharmaceutical products, following the announcement that ThromboGenics' has received FDA approval for the launch of JETREA® (ocriplasmin) in the USA for the treatment of Symptomatic Vitreomacular Adhesion (VMA).
Fujifilm Diosynth Biotechnologies Announces Strategic Alliance With Piramal Healthcare for Production of Antibody Drug Conjugates
Fujifilm Diosynth Biotechnologies has announced it has entered into a strategic alliance with Piramal Healthcare UK, whereby the two parties will offer the seamless contract development and manufacture of antibody drug conjugates (ADCs), a growing niche in the development of biopharmaceuticals.
Fujifilm Diosynth Biotechnologies has announced it is expanding its services in mammalian cell line development / process development and adding a new multiproduct cGMP facility at its Billingham, UK site, further increasing its contract process development and manufacturing capabilities.
Fujifilm Diosynth Biotechnologies has completed the first phase of a £3m ($4.5m) investment in new equipment and laboratories at its Billingham, UK site.
Fujifilm Diosynth Biotechnologies and ContraFect Corporation Collaborate for Novel Anti-Staph Biologic
Fujifilm Diosynth Biotechnologies and ContraFect Corporation have signed a contract to support the process development and cGMP manufacture of CF-301, ContraFect's Staphylococcal-specific bacteriophage lysin.
Fujifilm Diosynth Biotechnologies is to add a 1,000l Xcellerex® single-use bioreactor to its RTP, North Carolina facility, in order to expand its existing contract manufacturing capabilities. This expansion reinforces the commitment to lead the global biologics CMO industry through continuou
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